AccessGUDID - DEVICE: Titan™ Total Shoulder System (10381780120513)

GUDID

Device Identifier (DI) Information

Brand Name: Titan™ Total Shoulder System
Version or Model: SEM092002508
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STEM-0920-025-08
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780120513
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: The Titan Modular Total Shoulder press fit stem is shaped to provide proximal fixation. This stem has 1 mm incremental stem diameters located on it, along with 12 splines to contribute to an enhanced press fit and anti-rotation.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48090	Press-fit shoulder humeral stem prosthesis	A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural humerus to achieve a mechanical interlock without the use of bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142413	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3.86 in L x .356 in dia; Size 08

Device Record Status

Public Device Record Key: 40c0d5ae-74be-4357-969e-a4997b0f7415
Public Version Date: January 25, 2023
Public Version Number: 5
DI Record Publish Date: October 09, 2017